Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation

Pneumonia, Ventilator-Associated Clinical Trial

— RESPIRE  

Official title:

Impact of a Strategy Based on the PCR Testing System on Appropriate and Targeted Antimicrobial Treatment in Immunocompromised Patients With Suspected Ventilator-associated Pneumonia or Hospital-acquired Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05405491
• Other study ID #: 2021_0344
• Secondary ID: 2021-A02900-41
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Lille
• Contact: Marion HOUARD, MD
• Phone: 0320445962
• Email: marion.houard[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV

Exclusion Criteria:

• No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Immunodeficiency
• Immunologic Deficiency Syndromes
• Pneumonia
• Pneumonia, Hospital-Acquired
• Pneumonia, Ventilator-Associated

Intervention

Other:
• PCR based strategy
Early adjustment of antimicrobial therapy according to the results of a multiplex PCR-based testing, used in addition to standard microbiological culture of the tracheal aspirate, in immunocompromised patients with suspected VAP or HAP requiring MV
• Standard care
Broad-spectrum antimicrobial therapy adjustment after results of standard microbiological culture of the tracheal aspirate in immunocompromised patients with suspected VAP or HAP requiring MV

Locations

Country	Name	City	State
France	Houard	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in percentage of patients with targeted antibiotics	To determine the impact of a PCR-based strategy on the increase in percentage of patients with targeted antibiotics regimen 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care	24 hours after the initiation of empiric antimicrobial therapy
Secondary	Percentage of patients receiving appropriate anticrobial treatment	To determine the impact of a PCR-based strategy on the percentage of patients receiving approriate antimicrobial treatment 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care	24 hours after the initiation of empiric antimicrobial therapy
Secondary	Mechanical ventilation free days	To determine the impact of a PCR-based strategy on the amount of days alive and free from mechanical ventilation at day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care	28 days after the initiation of empiric antimicrobial therapy
Secondary	ICU Length of stay	To determine the impact of a PCR-based strategy on the length of stay in the Intensive Care Unit in the experimental group compared to standard care	Until 28 days after the initiation of empiric antimicrobial therapy
Secondary	28 days mortality	To determine the impact of a PCR-based strategy on the mortality at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care	28 days after the initiation of empiric antimicrobial therapy
Secondary	Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria	To determine the impact of a PCR-based strategy on the incidence of ICU-acquired infections and ICU-acquired colonization involving multidrug resistant bacteria at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care	28 days after the initiation of empiric antimicrobial therapy